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Characteristics of COVID-19 Infection Among PREGnant Women (CCOVID-PREG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04398264
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Luis M. Gomez, Inova Health System

Brief Summary:

In December 2019, Coronavirus infection (COVID-19) was identified as causing serious respiratory infection in humans. Initially COVID-19 was propagated by infected symptomatic individuals; currently the disease is disseminated by asymptomatic COVID-19 positive subjects. The prevalence of asymptomatic COVID-19 individuals is unknown.

Due its physiologic immune suppression, pregnancy is a vulnerable time for severe respiratory infections including COVID-19.

Limited information is available regarding the impact of COVID-19 in pregnancy and the prevalence and demographic profile of asymptomatic pregnant women.

Despite reports of 15-20% positive COVID-19 tests in women admitted to Labor and Delivery, professional obstetric medical societies still recommend not prioritizing testing of patients who are asymptomatic.

In the USA, COVID-19 symptomatic patients come predominantly from lower income, Black and Latino communities. No data are available on the rate and demographic distribution of asymptomatic positive COVID-19 pregnant women.

To minimize the risk of inadvertent exposure asymptomatic individuals, recently our institution started COVID-19 testing in all admitted pregnant women. The investigators expect to gain knowledge on the impact of COVID-19 in pregnant women especially if asymptomatic and compare to other respiratory infections.


Condition or disease Intervention/treatment
Corona Virus Infection Pregnancy Related Other: COVID-19 positive via testing

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Characteristics of COVID-19 Infection Among PREGnant Women
Actual Study Start Date : July 22, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: COVID-19 positive via testing
    Pregnant women admitted to Obstetric Units undergo RT-PCR testing for the detection of SARS-Cov2 (COVID-19 infection)


Primary Outcome Measures :
  1. Asymptomatic COVID-19 positive pregnant women [ Time Frame: Through completion of the study, an average of 1 year ]
    Rate of asymptomatic pregnant women who test positive for COVID-19 at the time of hospital admission


Secondary Outcome Measures :
  1. Asymptomatic Hispanic COVID-19 positive pregnant women [ Time Frame: Through completion of the study, an average of 1 year ]
    Rate of Hispanic pregnant women among those asymptomatic COVID-19 positive on admission

  2. Follow up of asymptomatic COVID-19 positive pregnant women [ Time Frame: Through completion of the study, an average of 1 year ]
    Rate of asymptomatic positive pregnant women who later will develop COVID-19 related symptoms

  3. COVID-19 positive newborns [ Time Frame: Through completion of the study, an average of 1 year ]
    Prevalence of COVID-19 positive newborns from infected mothers

  4. Severe COVID-19 disease in pregnant women [ Time Frame: Through completion of the study, an average of 1 year ]
    Rate of COVID-19 positive pregnant women who develop respiratory / multi-organ complications requiring admission to Medicine or Intensive Care units / maternal death related to COVID-19



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who presented to our Institution during the study period
Criteria

Inclusion Criteria:

  • >18 years-old
  • Pregnant women admitted to obstetric units (Labor and Delivery, Antepartum High Risk Pregnancy, pre-operative obstetric related surgeries as Cesarean or Cerclage) of Inova Health System hospitals

Exclusion Criteria:

- Pregnant women not tested for COVID-19


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398264


Contacts
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Contact: Luis M Gomez, MD. MScE 2677460601 luis.gomez@inova.org

Locations
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United States, Virginia
INOVA Health System Recruiting
Falls Church, Virginia, United States, 22042
Contact: Luis M Gomez, MD, MScE    703-698-5350    luis.gomez@inova.org   
Sponsors and Collaborators
Inova Health System
Publications:
CDC. Coronavirus Disease 2019 (COVID-19) in the U.S. Centers for Disease Control and Prevention. Published April 29, 2020. Accessed May 5, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html
CDC. Coronavirus Disease 2019 (COVID-19) - Transmission. Centers for Disease Control and Prevention. Published April 13, 2020. Accessed May 5, 2020. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html

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Responsible Party: Luis M. Gomez, Associate Professor, Inova Health System
ClinicalTrials.gov Identifier: NCT04398264    
Other Study ID Numbers: U20-05-4055
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Since COVID-19 in pregnant women is still a novel topic, we anticipate the need for collaboration with other researchers studying the effects of COVID-19 in pregnant women.

Individual participant data that underlie the results to be reported in our research would be available to be shared after deidentification (text, tables, figures and appendices) for individual participant meta-analysis.

Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our Institution's data warehouse but without investigator support other than deposited metadata.

Time Frame: Beginning 9 months and ending 36 months following article publication.

Information to be shared: Study Protocol, Results.

Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luis M. Gomez, Inova Health System:
COVID-19
SARS-Cov2
2019-nCoV
Vertical transmission
Asymptomatic positive
Pandemics
Universal screening
Obstetric
Viral infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases